Kornimate/medical-research-clean huggingface dataset:
impact of cbd-rich oil on aversive memory reconsolidation

Conditions: Anxiety and Fear

Summary: the purpose of this study is to test whether cannabidiol (cbd) rich hemp extract oil can interfere with the reconsolidation (storage) of pathological fear memory in humans.

preclinical experiments demonstrate that isolated cannabidiol (cbd), the non-psychotomimetic constituent of the cannabis sativa plant, disrupts reconsolidation of aversive memories conditioned in the laboratory when administered within the memory reconsolidation window (\< 6 hrs. post-retrieval) by indirectly activating cannabinoid type-1 (cb1) receptors in the dorsal anterior cingulate cortex (dacc). furthermore, background material (e.g., terpenoids) naturally present in the cannabis plant may also disrupt aversive memory reconsolidation both alone and in concert with cbd. based on these preclinical findings, we aim to test whether administration of 300mg cbd-rich hemp extract oil following fear reactivation of an aversive interoceptive threat memory can disrupt reconsolidation of naturalistic aversive memories in humans. more specifically, naturalistic interoceptive aversive memories, a form of transdiagnostic fear memory that contributes to the pathogenesis of fear-related disorders such as panic disorder, posttraumatic stress disorder (ptsd), and illness anxiety disorder. for this proof-of-concept double-blind trial, volunteers (n=96) reporting elevated fears of somatic sensations will be stratified on biological sex and baseline levels of interoceptive fear and randomized to one of three intervention arms: (a). cbd-rich oil administered within the reconsolidation window, (b). placebo oil administered within the reconsolidation window, or (c). cbd-rich oil administered outside of the reconsolidation window. change in emotional reactivity to a 35% co2 challenge from baseline to two-week follow-up will serve as our primary outcome. study findings may contribute towards the development of a novel ultra-brief transdiagnostic intervention guided by reconsolidation theory for individuals prone to fear-related psychiatric disorders.

Eligibility criteria:
inclusion criteria include: 1. ages 18-65 2. fluent in english 3. willingness to refrain from all non-study cannabis use during the study period. exclusion criteria include: 1. insufficient phobicity (\<50 on co2 challenge); 2. presence of significant suicidality; 3. history of psychosis; 4. currently receiving exposure-based treatment; 5. current substance use disorder; 6. unstable psychiatric medication for a psychological condition; 7. medical conditions contraindicating co2 inhalation (e.g., cardiac arrhythmia, cardiac failure, asthma, lung fibrosis, high blood pressure, epilepsy, or stroke); 8. any medical problems (e.g., liver or renal abnormalities) or medication use that would preclude ingesting cbd oil, including but not limited to currently taking blood thinners (e.g., warfarin and some anti-epileptic medications); 9. history of an adverse reaction to cbd oil or other cbd products, 10. coconut allergy (coconut oil is the carrier oil for cbd-rich extract) (l) regular cannabis use
a clinical study using adipose-derived stem cells for diabetic foot

Conditions: Peripheral Vascular Disease; Ischemia; Diabetic Foot

Summary: stem cell therapy has been a new and effective therapy in recent years for diabetic foot.this study intends to establish an optimal clinical research program, and attempts to break the technical bottleneck in the stem cell therapy for treating diabetes related vascular complications.

diabetic foot is one of the most serious chronic complications of diabetic patients, and still lacking effective treatments. stem cell therapy has been a new and effective therapy in recent years for diabetic foot. combined with the previous studies of our research group, this study intends to transform part of the results of this research, establish an optimal clinical research program, and attempts to break the technical bottleneck in the stem cell therapy for treating diabetes related vascular complications.

Eligibility criteria:
inclusion criteria: * diabetes mellitus type 2 or type 1 * age between 18-80 years * chronic foot ulcer more than 6 weeks * no sufficient response to best standard care delivered for six weeks. * pad up to fontaine stage iii or iv period * cli with the ankle brachial index (index ankle-brachial, abi) \<0.7 and (or) the -percutaneous oxygen partial pressure (oxygen tension transcutaneous, tcpo2) \<30mmhg exclusion criteria: * hba1c \>12% * hemoglobin \<10 mg/dl * creatinine clearance rate \<30ml/min * systemic bacterial, viral infections (mei du, hepatitis, cytomegalovirus infection, - hiv, b19 infection, herpes virus infection) and sepsis * have accepted the treatment of stem cells or growth factors * have a history of malignant disease * pregnancy * mental illness history * abnormal coagulation function * allergic reaction * severe cardiac insufficiency (iii-iv nyha) * using vasoactive substances

Keywords: adipose-derived stem cells
qualitative assessment of patients suffering from difficult asthma

Conditions: Asthma

Summary: asthma is a chronic inflammatory disease, resulting from environmental, genetic and immunological factors. this is a triad specific to the diseases of the 21st century, linked to our environment, which the investigators thought were perfectly characterized and stable and which presents us with new challenges in their management. our environment has not stopped changing over the past 30 years, so has our way of life and our way of working. the early detection of asthma and the initiation of an adequate therapy are most often carried out by primary care physicians, such as the general practitioner and the general pediatrician. these practitioners find themselves confronted with the medical complexity of asthma which essentially resides in the management of severe forms of asthma, defined by the high therapeutic charge needed to obtain a good control of the disease and, sometimes, in the management of difficult asthma which is an uncontrolled asthma independently of the patients' compliance and of the prescribed therapies. while general practitioners refer many cases of asthma to hospital experts, the investigators wanted to address the issue of difficult asthma, the management of which is less codified. the main objective of this work is to identify, by a qualitative analysis of medical records, the profiles of patients referred for difficult asthma in a tertiary hospital in order, secondly, to target individual characteristics or subgroups on which therapeutic actions could be implemented, and to provide educational support for doctors.


Eligibility criteria:
inclusion criteria: * patients assessed for difficult asthma, from december 2015 to november 2020, at the university hospital of montpellier * patients aged from 5 to 99 years exclusion criteria: * patients not affiliated to french social security * patients not capable of understanding french * patients who don't have a diagnosis of difficult asthma

Keywords: severe, difficult-to-treat asthma difficult asthma diagnosis comorbidities treatment allergy compliance
role of neutralizing antibodies in the prediction and treatment of bk virus infection in hematopoietic stem cell allograft patients at the pediatric oncology-hematology department of the hus

Conditions: BK Virus Infection

Summary: the bk virus (bkv) belongs to the polyomaviridae family. the primary infection, generally asymptomatic, occurs during childhood. the virus then persists in latent form in the body, mainly in the epithelial cells of the kidney and urinary tract. cellular immunosuppression favors bkv replication. it is responsible for pathologies of the renal-urinary tract such as bkv-associated nephropathy (bkvan) in kidney transplant recipients, hemorrhagic cystitis (hc) in hematopoietic stem cell (hsc) recipients or ureteral stenosis. to date, there is no specific antiviral treatment against bkv. the management of patients is essentially symptomatic and requires a multidisciplinary approach. it is therefore necessary to identify early prognostic markers for the occurrence of ch and to develop new therapeutic strategies.


Eligibility criteria:
inclusion criteria: * adult patient aged 18 to 19 years * minor patient (from birth to 17 years old) * hsc allograft patient managed by the pediatric oncology-hematology service of the hus, between 01/01/2015 and 31/12/2019 exclusion criteria: * opposition of the patient (or parental authority holders) to participate in the study * biological resources from a patient who does not meet all inclusion criteria * patient deprived of liberty or under court protection * patient under guardianship or curatorship

Keywords: bk virus infection neutralizing antibodies hematopoietic stem cell polyomaviridae
re-trabeculectomy versus ahmed glaucoma valve implantation in secondary surgical management of patients with refractory glaucoma

Conditions: Refractory Primary Open Angle Glaucoma

Summary: the purpose of this study is to compare three-year outcomes of re-trabeculectomy with those of ahmed glaucoma valve implantation in secondary surgical management of patients with primary open angle glaucoma (poag) and a history of previous failed trabeculectomy.

currently, lowering intraocular pressure (iop) is the only treatment modality to prevent or slow progression of glaucomatous optic nerve damage. incisional procedures are indicated when medical therapy and/or laser procedures cannot adequately reduce iop. trabeculectomy is the most common glaucoma incisional procedure globally. on the other hand, glaucoma drainage devices that have been historically reserved for cases of glaucoma deemed at high risk of failure have increasingly gained popularity particularly in eyes with previous history of glaucoma surgery. there is still no agreement on the appropriate surgical procedure in those with prior glaucoma surgery. the five-year tube versus trabeculectomy (tvt) study, which evaluated the efficacy and safety of baerveldt glaucoma implant versus trabeculectomy, showed that both surgical procedures had similar iop reduction and use of anti-glaucoma medication; tube shunt surgery had a higher success rate than trabeculectomy with mitomycin c (mmc); the trabeculectomy/mmc had higher incidence of early postoperative complications compared to tube shunt surgery; and rates of late postoperative complications, reoperation for complications, and cataract extraction were comparable in both treatment groups. in this study, the investigators compared three-year outcomes of re-trabeculectomy with those of ahmed glaucoma valve implantation in secondary surgical management of patients with primary open angle glaucoma and a previous history of failed trabeculectomy.

Eligibility criteria:
inclusion criteria: * uncontrolled glaucoma defined as (1) iop not achieving previously assigned target pressure despite prior trabeculectomy and use of maximally tolerated anti-glaucoma medication; and (2) recent progression of the disease based on glaucomatous changes in optic disc appearance and/or worsening of the visual field exam. * in the case of two eligible eyes, only the first eye being operated on was enrolled exclusion criteria: * younger than 40 years old * visual acuity of no light perception * lens opacity * elevated iop associated with silicone oil * prior ocular surgeries other than one trabeculectomy with mmc * previous cyclodestructive treatment * increased risk of endophthalmitis * posterior segment disorders * pre-existing ocular comorbidities (e.g. pterygium,phacodonesis,corneal opacity, or corneal endothelial dystrophies)

Keywords: refractory primary open angle glaucoma trabeculectomy ahmed valve implant
smart textile ecg monitoring

Conditions: Cardiac Arrhythmia

Summary: this research is a clinical evaluation of the skiin chest band, a smart garment with embedded electronic textile (e-textile) electrodes, to record body surface electrocardiogram (ecg) signals. developed by myant textile computing inc., the skiin chest band (i.e. as part of the skiin underwear family of garments) is a component of the myant health platform (mhp). the mhp also consists of: (a) a mobile phone application (skiin connected life application; scla), and (b) the myant virtual clinic portal (mvcp). in this study, participants will wear the skiin chest band to collect their ecg for a period of 14 days. participants will also be provided with a smartphone that is pre-loaded with the scla to record any symptoms (e.g. palpitations, shortness of breath, fatigue, light- headedness, fainting, etc.) they may experience over the 14 day ecg monitoring period. the data collected in this study will be used to develop new algorithms and patient monitoring tools to detect and predict cardiovascular health problems.


Eligibility criteria:
inclusion criteria: * being referred to the partners in advanced cardiac evaluation (pace cardiology), and having been prescribed a 14-day ambulatory ecg monitoring by their physician. * able to understand and speak english language, enough to provide informed consent. exclusion criteria: * age \< 18 years * pregnancy * cardiovascular implantable electronic devices (cied), including implanted cardioverter defibrillator (icd) or pacemakers * absence of chest band that fits the participant's body * open wound or dressing on a body part that needs to be in contact with the skiin garment

Keywords: smart textile ambulatory electrocardiogram monitoring holter monitoring arrhythmia detection textile electrodes
a study to evaluate pharmacokinetics, safety and tolerability of medi0382 in renal impairment subjects

Conditions: Renal Insufficiency

Summary: a phase 1 open-label, single-dose study to evaluate the pharmacokinetics (pk), safety, tolerability and immunogenicity of medi0382 in subjects with renal impairment.

this is an open-label, single-dose, parallel group study to evaluate the pk, safety, tolerability, and immunogenicity of medi0382 in subjects with renal impairment. enrollment of approximately 40 subjects across multiple sites is planned. subjects will be divided into 4 groups based on renal function.

Eligibility criteria:
inclusion criteria: * must provide written informed consent * bmi greater than or equal to 17 and less than or equal to 40 kg/m2 * creatinine clearance rate greater than or equal to 90 (healthy); or renally impaired (less than 60 ml/min) * females of childbearing potential must use a highly effective form of contraception. exclusion criteria: * any history of or concurrent condition that in the opinion of the investigator would compromise the subjects safety. * subjects on dialysis * subjects with pancreatitis * renal transplant subjects * females pregnant or lactating

Keywords: kidney failure, kidney insufficiency, renal failure, renal insufficiency, medi0382
clinical and urodynamic effects of minimally laser (incontilasetm) procedure for female stress urinary incontinence

Conditions: Stress Urinary Incontinence

Summary: the purpose of this study is to get the effect of incontilasetm procedure; and its impact on urinary symptoms and female sexual function.

to get the objective urodynamic and sonographic effects of incontilasetm procedure on women with stress urinary incontinence; and its impact on urinary symptoms and female sexual function.

Eligibility criteria:
inclusion criteria: * all consecutive sexually active and parous adult women with the complaint of stress urinary incontinence exclusion criteria: * \< 20 years old female
tetra-nirs clinical study

Conditions: Lower Urinary Tract Symptoms; Overactive Bladder

Summary: the purpose of this evaluation is to validate the previous clinical study results using a near-infrared spectroscopy (nirs) device, as compared to the conventional urodynamics (uds) testing. the experiment will use the commercially available tetra-nirs and laborie uds equipment. the hypothesis is that the tetra-nirs device, in the clinical environment, provides data to enhance the analysis using the standard urodynamics equipment (stand-alone urodynamic procedure).

this is a study of the commercially available tetra-nirs device to compare the results collected against conventional urodynamics. the study will evaluate male patients with lower urinary tract symptoms (luts) as well as female subjects with over-active bladder (oab). the tetra-nirs unit uses near infrared light at 3 different wavelengths to measure changes in haemoglobin and cytochrome from the detrusor muscle from the human bladder wall. this process is similar to what is used for cerebral and muscle oxygenation monitoring (e.g., pulse oximetry). previous clinical feasibility studies have identified the correlation between the changes in haemoglobin and cytochrome of the bladder, and bladder pressure values obtained during urodynamics procedures and uroflow procedures. for this study the tetra-nirs results will not be used by the urologist/nurse to guide in patient management and treatment decisions, but rather will only be used to collect measurements from the patient for the purposes of this study. the tetra-nirs sensor patch will be adhered externally to the skin surface where the bladder is located. for this study, a minimum of 30 male subjects with luts and 30 female subjects with oab scheduled to undergo a urodynamics procedure are to be enrolled. up to 20 female subjects with oab will be enrolled. the investigators will attempt to equally enrol male subjects into each of the two categories including obstructed and non-obstructed groups according to prostate hyperplasia (equivocal subjects will be determined by the investigator).

Eligibility criteria:
inclusion criteria: * the selection of subjects enrolled for testing must meet the following criteria: * subjects must be 18 years of age or older. * subjects are patients of one of the institutions and are currently scheduled for uds * male subjects must have luts * female subjects must have oab * subjects must give their informed consent prior to enrolment. exclusion criteria: * the patient has an existing health condition which the investigators feel will not allow for safe or accurate measurements with the tetra-nirs device.

Keywords: luts oab
monoclonal antibodies elimination in breast cancer patient

Conditions: Breast Cancer

Summary: this study evaluates covariables being able to potentially influence the elimination of the monoclonal antibodies (trastuzumab, bevacizumab and denosumab).

monoclonal antibodies are very widely used in cancer treatment . certain patients benefit from these antibodies for several years and it is conceivable to wonder about the evolution of the pharmacokinetics of these antibodies.

Eligibility criteria:
inclusion criteria: * a diagnosed cancer * patient treated by bevacizumab or trastuzumab * life expectancy of at least 3 months * for the women: menopausal women for at least 24 months, sterilized surgically, or, for the women old enough to procreate, use a method of effective contraception (oral contraceptives, contraceptive injections, intra-uterine devices, method of the double barrier, the contraceptive patches). this contraception will have to be pursued during 6 months after the end of the treatment by bevacizumab or by trastuzumab. exclusion criteria: * for patients treated by trastuzumab: dyspnoea of severe rest in touch with complications due to the disease or requiring an oxygen therapy. * hypocalcemia severe untreated
vaginal misoprostol in medical treatment of first trimester missed miscarriage

Conditions: Miscarriage

Summary: efficacy of vaginal misoprostol 600 mg versus 800 mg in termination of the first trimester missed abortion were assist

in women with first trimetric-missed miscarriage, vaginal misoprostol in the achievement of successful miscarriage so our aim was to compare the effectiveness of vaginal misoprostol 600 mg versus 800 mg for medical treatment of the first trimester missed miscarriage.

Eligibility criteria:
inclusion criteria: * all women above 18 years of age * less than 12 weeks of gestation. * pregnancy is confirmed by pregnancy test or ultrasound scan. * missed abortion * normal general and gynecological examination. exclusion criteria: * hemodynamically unstable. * suspected sepsis with temperature 38 °c. * concurrent medical illness e.g. hematological, cardiovascular, thromboembolism, * respiratory , recent liver disease, or pruritus of pregnancy. * presence of intrauterine contraceptive device (iucd). * suspect or proven ectopic pregnancy. * failed medical or surgical evacuation before the presentation. * known allergy to misoprostol.

Keywords: miscarriage vaginal misoprostol
trial of an investigational drug after rejecting the relapse of an allogeneic transplant

Conditions: Multiple Myeloma; Allogeneic Stem Cell Transplantation

Summary: most patients with multiple myeloma (mm) die due to relapse resistant to current treatment, including treatment with anti-b cell maturation antigen (bcma) car-t cells. to overcome some of the potential limitations of this therapy, a new and optimized anti-bcma car-t has been developed, with the aim of using it in patients with mm who relapse after allogeneic haematopoietic haematopoietic progenitor. this trial is a prospective phase i/ii trial with a 3+3 design. once dose limiting toxicity is identified, phase ii will begin to assess the efficacy of the procedure.

this trial is a prospective phase i/ii trial with a 3+3 design. once dose limiting toxicity is identified (up to a maximum dose of 6x106 car-t/kg divided over 2 days), phase ii of the trial will begin to assess the efficacy of the procedure. a number of 25 patients will be included to evaluate.

Eligibility criteria:
inclusion criteria: 1. patients \> 18 years old with a diagnosis of post-allogeneic transplant relapse multiple myeloma. 2. measurable disease at the time of screening 3. previous treatment with ≥2 lines before and/or after allogeneic transplant. 4. patients who are not receiving immunosuppressants at least 1 month before inclusion and who do not have active graft-versus-host disease. 5. eastern cooperative oncology group functional status from 0 to 1. 6. life expectancy greater than 3 months (at the time of screening) 7. patients who give their consent by signing the informed consent document. exclusion criteria: 1. active systemic immunosuppressive treatment 2. patients who have previously received treatment with car-t anti-bcma. 3. absolute lymphocyte count \<0.2x109/l 4. previous neoplasm, except if it has been in complete remission \>3 years, with the exception of skin carcinoma (non-melanoma) 5. active infection requiring treatment. 6. active hiv, hepatitis b virus or hepatitis c virus infection. 7. uncontrolled medical illness. 8. severe organic disease that meets any of the following criteria: left ventricular ejection fraction \ 3 normal value (except gilbert syndrome). 9. previous diagnosis of symptomatic amyloid light chain or primary amyloidosis or poems syndrome. 10. pregnant or lactating women. 11. women of childbearing age, unable or unwilling to use highly effective contraceptive methods. 12. men who cannot or do not wish to use highly effective contraceptive methods. the partner of the male participants, if they are women of childbearing age, must also use highly effective contraceptive methods during the study period. 13. contraindication to receive lymphodepleting chemotherapy. 14. patients with known hypersensitivity to the active ingredients or any of the excipients of the product to be infused.

Keywords: chimeric antigen receptor-t cell therapy b-cell maturation antigen